Bardex Lubri-Sil All-Silicone Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,069
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls
- 0
We found 21 models of Bardex Lubri-Sil All-Silicone Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,069 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Sep 30, 2026 — classified as 76 injuries, 993 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (260 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardex Lubri-Sil All-Silicone Foley Catheter problems
Device problems
- Material Puncture/Hole260
- Material Rupture143
- Difficult to Remove112
- Material Split, Cut or Torn85
- Fluid/Blood Leak72
- Deflation Problem71
- Inflation Problem69
- Material Fragmentation58
Patient problems
- No Clinical Signs, Symptoms or Conditions759
- No Known Impact Or Consequence To Patient140
- No Consequences Or Impact To Patient129
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available71
- Pain38
- Discomfort24
- Foreign Body In Patient17
- Patient Problem/Medical Problem12
Bardex Lubri-Sil All-Silicone Foley Catheter models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175808CATHETER, RETENTION TYPE, BALLOON42 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175806NCATHETER, RETENTION TYPE, BALLOON31 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 73022LCATHETER, RETENTION TYPE, BALLOON30 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175818CATHETER, RETENTION TYPE, BALLOON29 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175810CATHETER, RETENTION TYPE, BALLOON15 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 73016LCATHETER, RETENTION TYPE, BALLOON11 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 73018LCATHETER, RETENTION TYPE, BALLOON8 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175820CATHETER, RETENTION TYPE, BALLOON7 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 176816CATHETER, RETENTION TYPE, BALLOON7 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 73024LCATHETER, RETENTION TYPE, BALLOON5 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 70518LCATHETER, RETENTION TYPE, BALLOON5 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175824CATHETER, RETENTION TYPE, BALLOON3 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 176820CATHETER, RETENTION TYPE, BALLOON3 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 73020LCATHETER, RETENTION TYPE, BALLOON3 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 70516LCATHETER, RETENTION TYPE, BALLOON3 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175822CATHETER, RETENTION TYPE, BALLOON2 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 176822CATHETER, RETENTION TYPE, BALLOON1 report
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 176824CATHETER, RETENTION TYPE, BALLOON1 report
Recent Bardex Lubri-Sil All-Silicone Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952619 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926179 ↗MalfunctionSep 28, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923637 ↗MalfunctionSep 28, 2026Material Rupture
It was reported that small puncture in catheter near connecting end resulting in continuous urine leakage. Balloon burst resulting in catheter falling out. Potentially dangerous situation because high risk of autonomic dysreflexia. Catheter only changed one day previously. Re-catheterised with different model catheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916264 ↗MalfunctionSep 24, 2026Material Fragmentation
It was reported that the customer had a Bard Medical 14Fr Foley tray system catheter (Reference: (b)(4) was placed on the patient for intravesical chemotherapy. When the nurse went to instill the chemotherapy, the needle-free sampling port, where the Equashield connector was to be attached, was noted to be missing or broken, preventing attachment of the Equashield device for chemotherapy administration. The drainage bag and tubing were removed, and a new bag (Medline Add-A-Cath) was attached to the catheter, which had the correct port. The customer stated that the same issue was observed in multiple kits from the same lot number on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889830 ↗MalfunctionSep 4, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614133 ↗InjurySep 3, 2026Difficult to Remove
It was reported from New Brunswick on (b)(6) 2026 that an 8Fr Foley catheter (REF (b)(4), LOT NGKU0844) was inserted into a patient in the Pediatric Intensive Care Unit with 5 mL instilled into the balloon as per the product instructions. The catheter was subsequently removed due to the patient voiding around the Foley. When removal was attempted, the RN was unable to withdraw more than 4.2 mL from the balloon and encountered resistance during catheter removal. The physicians were notified, and manipulation under ultrasound guidance was required to facilitate removal of the Foley catheter. Upon removal, the balloon was observed to remain partially inflated on one side. No bleeding or swelling was noted in the patient.
Patient problems: Insufficient Information
MAUDE report 50578070 ↗MalfunctionSep 2, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563775 ↗MalfunctionJul 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833865 ↗MalfunctionJul 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25787494 ↗MalfunctionJun 27, 2026Material Rupture
IT WAS REPORTED THAT THE FOLEY BALLOON BROKE AFTER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646120 ↗MalfunctionJun 25, 2026Inflation Problem
INSERTED CATHETER AS THE BALLOON WAS BEING INFLATED THE WATER CAME OUT AND THE TOP WHITE CONNECTOR CAME AWAY FROM THE CATHETER. THE SYRINGE IS RESISTING WHEN PUSHING DOWN ON IT ALSO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628390 ↗MalfunctionJun 25, 2026Material Puncture/Hole
INSERTED CATHETER AS THE BALLOON WAS BEING INFLATED THE WATER CAME OUT AND THE TOP WHITE CONNECTOR CAME AWAY FROM THE CATHETER. THE SYRINGE IS RESISTING WHEN PUSHING DOWN ON IT ALSO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626475 ↗MalfunctionJun 5, 2026Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON EXPLODED WHEN INFLATED. CUSTOMER UNSURE IF THIS HAPPENED PRIOR TO FOLEY INSERTION OR AFTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410455 ↗MalfunctionJun 5, 2026Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON EXPLODED WHEN INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410444 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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